CN106880428B - A kind of bioabsorbable stent system and method - Google Patents
A kind of bioabsorbable stent system and method Download PDFInfo
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- CN106880428B CN106880428B CN201710191402.8A CN201710191402A CN106880428B CN 106880428 B CN106880428 B CN 106880428B CN 201710191402 A CN201710191402 A CN 201710191402A CN 106880428 B CN106880428 B CN 106880428B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
- B29L2031/7534—Cardiovascular protheses
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Mechanical Engineering (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The present invention provides a kind of bioabsorbable stent system and methods, wherein the bioabsorbable stent system includes: foley's tube, foley's tube includes sacculus and inner tube, and one end of inner tube passes through sacculus and exposes to sacculus, and inner tube is located at the position in sacculus equipped with the first development point and the second development point；Bioabsorbable stent, bioabsorbable stent is sheathed on the outside of sacculus, and bioabsorbable stent is located between the first predeterminated position and the second predeterminated position of sacculus, and bioabsorbable stent fits with sacculus；Bioabsorbable stent is the frustum cone structure with default taper, and the outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of the proximal end of bioabsorbable stent.Wherein, the first predeterminated position is position corresponding with the first development point on sacculus, and the second predeterminated position is position corresponding with the second development point on sacculus.The embodiment of the present invention can promote bioabsorbable stent system in the handling capacity of lesion vessels and small size blood vessel.
Description
Technical field
The present invention relates to medical devices field, in particular to a kind of bioabsorbable stent system and method.
Background technique
Coronary intervention technology is developed so far existing more than 40 year, sends out from the balloon dilatation of early stage, bare bracket implantation
The biological absorbable support for opening up bracket for eluting medicament or even today, constantly pushes Coronary Artery Disease Intervention Treatment to improve forward.
Currently, the factors such as the quickening of work and life rhythm and unscientific eating habit, the shortage of self health consciousness, lead to the heart
Vascular morbidity rate is higher and higher, and the number that cardiovascular disease is died of in the whole world every year is up to 15,000,000 people, occupies the various causes of the death
It is the first.China's cardiovascular patient alreadys exceed 2.7 hundred million people！China dies of the people nearly 3,000,000 of cardiovascular disease every year, accounts for me
State every year total Death causes 51%.And with aging of population trend, cardiovascular illness rate is also in lasting rising.
And at present permanent metal bracket there are many urgent problems to be solved, such as patient it is postoperative need to be used for a long time it is anticoagulant
Drug to avoid support portions thrombosis, but still it is difficult avoid thrombosis completely, and may cause the big bleeding of mortality.
Postoperative restenosis rate can be made to be down to 3% hereinafter, but for chronic support portions even with medicament elution metallic support
Irritation endometrial hyperplasia there is no effective therapeutic scheme, some studies pointed out that therefore caused by support in blood-vessel long-term postoperative it is unobstructed
Rate is even lower than simple sacculus urethroptasty, and in addition patient cannot receive nuclear magnetic resonance check after implanted metal bracket.These all may be used
Can restrict metallic support for a long time and extensive clinical application.
In order to solve in vascular interventional treatment because of the above problem brought by stenter to implant, complete biological absorbable blood vessel
Bracket comes into being.The bracket also has medicine-carried, is able to suppress endometrial hyperplasia, adds in addition to having the function of expansion support
The effects of fast endothelial cell growth.After having given full play to its function, which gradually degrades in vivo, is finally degraded to
Human body can absorb non-toxic products such as water and carbon dioxide, and the blood vessel after bracket can be made to disappear restores nature.
And influenced by the material of bioabsorbable stent, to obtain the stronger support strength of bracket, so that bioabsorbable stent needs
Cradling piece width and wall thickness that will be bigger, so that pressing the diameter of the bioabsorbable stent after holding more compared to metallic support
Greatly, so that significantly limiting bioabsorbable stent system passes through the ability of small size blood vessel and tortuous lesion vessels.
Summary of the invention
The embodiment of the present invention is designed to provide a kind of bioabsorbable stent system and method, can promote bioabsorbable stent system
It unites in the handling capacity of lesion vessels and small size blood vessel.
In order to achieve the above object, the embodiment provides a kind of bioabsorbable stent systems, comprising:
Foley's tube, foley's tube include sacculus and inner tube, and one end of inner tube passes through sacculus and exposes to sacculus, inner tube position
The first development point and the second development point are equipped in the position in sacculus；
Bioabsorbable stent, bioabsorbable stent is sheathed on the outside of sacculus, and bioabsorbable stent is located at the first of sacculus and presets
Between position and the second predeterminated position, bioabsorbable stent fits with sacculus；Bioabsorbable stent is the rotary table with default taper
Structure, and the outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of the proximal end of bioabsorbable stent,
Wherein, the first predeterminated position is position corresponding with the first development point on sacculus, and the second predeterminated position is on sacculus
Position corresponding with the second development point.
Wherein, presetting taper is 0.008~0.017.
Wherein, bioabsorbable stent is made of absorbable polymer polymer material.
The embodiments of the present invention also provide a kind of methods for preparing bioabsorbable stent system, this method comprises:
Precompressed is carried out to bioabsorbable stent and holds processing, the outer diameter of bioabsorbable stent is pressed and holds to default outer diameter, obtain pre-
Pressure holds that treated bioabsorbable stent；
Precompressed bioabsorbable stent of holding that treated is sheathed on to the outside of the sacculus of foley's tube, the first pressure is obtained and holds knot
Structure；Wherein, precompressed holds that treated bioabsorbable stent is located between the first predeterminated position and the second predeterminated position of sacculus, and first
Predeterminated position is position corresponding with the first development point of foley's tube on sacculus, and the second predeterminated position is to lead on sacculus with sacculus
The corresponding position of the second development point of pipe；
It holds the secondary pressure of structure progress to the first pressure to hold, the bioabsorbable stent after holding secondary pressure fits with sacculus, is secondary
Bioabsorbable stent after pressure is held is in the outer of the frustum cone structure and the secondary distal end for pressing the bioabsorbable stent after holding for presetting taper
Diameter is less than the outer diameter of proximal end, obtains bioabsorbable stent system.
Wherein, precompressed is carried out to bioabsorbable stent and holds processing, pressed the outer diameter of bioabsorbable stent and hold to default outer diameter, obtain
The step of to precompressed bioabsorbable stent of holding that treated, comprising:
Bioabsorbable stent is sheathed on to the outside of a support construction, the second pressure is obtained and holds structure；
By first pressure hold machine according to it is pre-set first pressure hold configuration, to second pressure hold structure carry out pressure hold, up to
The reduction that first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount；
It repeats and presses machine of holding to hold configuration according to pre-set first pressure by first, structure is held to the second pressure and is pressed
It holds, until the step of reduction that the first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount, until absorbable branch
The outer diameter of frame, which is pressed, to be held to default outer diameter；
From pressure hold after the second pressure hold and detach bioabsorbable stent in structure, obtain precompressed absorbable branch of holding that treated
Frame.
Wherein, first pressure hold configuration include: the first preheating temperature, the first preheating time, first pressure hold machine first pressure hold
The first diameter in hole, the reduction rate of first diameter and the first molding retention time,
Wherein, the first diameter that multiple first pressures that the first pressure holds that machine is included hold hole is identical.
Wherein, predetermined amount is the preset percentage of the current outer diameter of bioabsorbable stent.
Wherein, the secondary pressure of structure progress is held to the first pressure to hold, the secondary bioabsorbable stent pressed after holding and sacculus is made to fit,
Bioabsorbable stent after secondary pressure is held is in the frustum cone structure with default taper and the secondary distal end for pressing the bioabsorbable stent after holding
Outer diameter be less than the outer diameter of proximal end, the step of obtaining bioabsorbable stent system, comprising:
The second pressure by having default taper holds machine and holds configuration according to pre-set second pressure, carries out to foley's tube
Pressurising, and structure is held to the first pressure carry out pressure and hold, until the pressure grip value that the second pressure holds machine feedback reaches default pressure grip value, make
Bioabsorbable stent after the secondary bioabsorbable stent pressed after holding and sacculus fit, secondary pressure is held is in the rotary table for presetting taper
The outer diameter of structure and the secondary distal end for pressing the bioabsorbable stent after holding is less than the outer diameter of proximal end, obtains bioabsorbable stent system.
Wherein, presetting pressure grip value is 150N~300N.
Wherein, the second pressure holds configuration and includes: the second preheating temperature, the second preheating time, carries out pressurising to foley's tube
The second pressure that filling pressure force value, the second pressure hold machine is held the second diameter in hole, the reduction rate of second diameter and the second molding and is protected
The time is held,
Wherein, the second pressure holds the pressure that hole is the distal end cooperation that the second pressure holds on machine bioabsorbable stent of holding that treated with precompressed
The pressure for holding piece holds hole.
Wherein, the second preheating temperature is 45 DEG C to 55 DEG C, and the second preheating time was 10s to 60s, is filled to foley's tube
The filling pressure force value of pressure is 80~220psi, the outer diameter phase of the distal end of second diameter and precompressed hold that treated bioabsorbable stent
Together, the reduction rate of second diameter is 0.01mm/s to 0.2mm/s, and the second molding retention time was 20s to 180s.
Above scheme of the invention is include at least the following beneficial effects:
In an embodiment of the present invention, since the bioabsorbable stent of bioabsorbable stent system is the rotary table with default taper
Structure, and the outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of proximal end, so that during pushing bioabsorbable stent system,
Bioabsorbable stent system can be promoted in the handling capacity of lesion vessels and small size blood vessel, while bioabsorbable stent can also be reduced
The risk being detached from sacculus, effectively improves the safety that bioabsorbable stent uses.
Detailed description of the invention
Fig. 1 is the schematic diagram of bioabsorbable stent system in the embodiment of the present invention；
Fig. 2 is the flow chart that the method for bioabsorbable stent system is prepared in the embodiment of the present invention；
Fig. 3 is one of the developed surface schematic diagram of bioabsorbable stent in the embodiment of the present invention；
Fig. 4 is two of the developed surface schematic diagram of bioabsorbable stent in the embodiment of the present invention；
Fig. 5 is that the pressure that the second pressure holds machine in the embodiment of the present invention holds one of schematic diagram of piece；
Fig. 6 is the two of the schematic diagram that the pressure that the second pressure holds machine in the embodiment of the present invention holds piece；
Fig. 7 is the schematic diagram that the pressure that the first pressure holds machine in the embodiment of the present invention holds piece；
Fig. 8 is the schematic diagram that the second pressure holds machine in the embodiment of the present invention；
Fig. 9 is the schematic diagram that the first pressure holds machine in the embodiment of the present invention.
Specific embodiment
Exemplary embodiments of the present disclosure are described in more detail below with reference to accompanying drawings.Although showing the disclosure in attached drawing
Exemplary embodiment, it being understood, however, that may be realized in various forms the disclosure without should be by embodiments set forth here
It is limited.On the contrary, these embodiments are provided to facilitate a more thoroughly understanding of the present invention, and can be by the scope of the present disclosure
It is fully disclosed to those skilled in the art.
As shown in Figure 1, specific embodiments of the present invention provide a kind of bioabsorbable stent system, the bioabsorbable stent system
It include: foley's tube, foley's tube includes sacculus 1 and inner tube 2, and one end of inner tube 2 passes through sacculus 1 and exposes to sacculus 1, inner tube
2 positions for being located in sacculus 1 are equipped with the first development point and the second development point；Bioabsorbable stent 3, bioabsorbable stent 3 are sheathed on
The outside of sacculus 1, and bioabsorbable stent 3 is located between the first predeterminated position and the second predeterminated position of sacculus 1, bioabsorbable stent
3 fit with sacculus 1；Bioabsorbable stent 3 is the frustum cone structure with default taper, and the outer diameter of the distal end of bioabsorbable stent 3
Less than the outer diameter of the proximal end of bioabsorbable stent 3.
Wherein, above-mentioned first predeterminated position is position corresponding with the first development point on sacculus 1, and the second predeterminated position is ball
Position corresponding with the second development point on capsule 1.
Wherein, in a specific embodiment of the present invention, above-mentioned sacculus 1 can be used high molecular material and be made, for example, by using Buddhist nun
Dragon, polyamide etc. are made.Of course, it should be understood that in an embodiment of the present invention, not limiting the specific material of above-mentioned sacculus 1
Matter.
Wherein, in a specific embodiment of the present invention, above-mentioned default taper can be 0.008~0.017, preferably 0.01,
To help to be promoted bioabsorbable stent system in the handling capacity of lesion vessels and small size blood vessel.
Wherein, in a specific embodiment of the present invention, absorbable polymer polymer can be used in above-mentioned bioabsorbable stent 3
Material is made, so that bioabsorbable stent 3, after having given full play to its function, which gradually drops in vivo
Solution, is finally degraded to the absorbable non-toxic products of human body, and the blood vessel after bioabsorbable stent 3 can be made to disappear restores nature.Certainly may be used
With understanding, in an embodiment of the present invention, the specific material of above-mentioned bioabsorbable stent 3 is not limited.
Wherein, in a specific embodiment of the present invention, the wall thickness of above-mentioned bioabsorbable stent 3 can be 100 to 150 microns,
The outer diameter of the distal end of bioabsorbable stent 3 can be 0.8 to 1.2 millimeter, and the outer diameter of the proximal end of bioabsorbable stent 3 is 1.0 to 1.4 millis
Rice.But it should be recognized that the outer diameter of the distal end of bioabsorbable stent 3 need to be less than the outer diameter of the proximal end of bioabsorbable stent 3, thus really
Handling capacity of the bioabsorbable stent system in lesion vessels and small size blood vessel is protected, the applicable model of bioabsorbable stent is increased
It encloses.It should be noted that the specific size of bioabsorbable stent 3 can carry out adjustment appropriate according to actual needs.
As it can be seen that in a specific embodiment of the present invention, since the bioabsorbable stent of bioabsorbable stent system is with default
The frustum cone structure of taper, and the outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of proximal end, so that in push bioabsorbable stent system
During system, bioabsorbable stent system can be promoted in the handling capacity of lesion vessels and small size blood vessel, while can also drop
The risk that low bioabsorbable stent and sacculus 1 are detached from, effectively improves the safety that bioabsorbable stent uses.
As shown in Fig. 2, specific embodiments of the present invention additionally provide a kind of method for preparing bioabsorbable stent system, the party
Method includes:
Step 201, precompressed is carried out to bioabsorbable stent and holds processing, pressed the outer diameter of bioabsorbable stent and hold to default outer
Diameter obtains precompressed bioabsorbable stent of holding that treated.
Wherein, in an embodiment of the present invention, before carrying out precompressed to bioabsorbable stent and holding processing, the bioabsorbable stent
Developed surface after strutting can be the developed surface of bioabsorbable stent 3 as shown in Figure 3.
And in a specific embodiment of the present invention, the main function of above-mentioned steps 201 are as follows: by the outer diameter pressure of bioabsorbable stent
It holds to default outer diameter, such as 1.6 to 1.9 millimeters (mm), so that the bioabsorbable stent can enter subsequent process.
Step 202, precompressed bioabsorbable stent of holding that treated is sheathed on to the outside of the sacculus of foley's tube, obtains first
Pressure holds structure.
Wherein, precompressed bioabsorbable stent of holding that treated be located at sacculus the first predeterminated position and the second predeterminated position it
Between, the first predeterminated position is position corresponding with the first development point of foley's tube on sacculus, and the second predeterminated position is on sacculus
Position corresponding with the second development point of foley's tube.
Wherein, above-mentioned foley's tube includes sacculus and inner tube, and one end of inner tube passes through sacculus and exposes to sacculus, and inner tube
Position in sacculus is equipped with the first development point and the second development point.
Step 203, it holds the secondary pressure of structure progress to the first pressure to hold, the bioabsorbable stent after holding secondary pressure is affixed with sacculus
It closes, the secondary bioabsorbable stent pressed after holding is in the bioabsorbable stent after holding with the frustum cone structure and secondary pressure for presetting taper
The outer diameter of distal end is less than the outer diameter of proximal end, obtains bioabsorbable stent system.
Wherein, in a specific embodiment of the present invention, after having executed above-mentioned steps 203, bioabsorbable stent has default
Taper, and the developed surface of the bioabsorbable stent can be the developed surface of bioabsorbable stent 3 as shown in Figure 4.
Wherein, in a specific embodiment of the present invention, the specific implementation of above-mentioned steps 203 are as follows: default by having
Second pressure of taper holds machine and holds configuration according to pre-set second pressure, carries out pressurising to foley's tube, and hold knot to the first pressure
Structure carries out pressure and holds, until the pressure grip value that the second pressure holds machine feedback reaches default pressure grip value, it is absorbable after holding secondary pressure
Bioabsorbable stent after bracket and sacculus fit, secondary pressure is held is in after holding with the frustum cone structure and secondary pressure for presetting taper
Bioabsorbable stent distal end outer diameter be less than proximal end outer diameter, obtain bioabsorbable stent system.
Wherein, in a specific embodiment of the present invention, above-mentioned default taper can be 0.008~0.017, preferably 0.01；
Above-mentioned default pressure grip value can be 150N~300N, preferably 180N.Of course, it should be understood that in specific implementation of the invention
In example, the specific value of above-mentioned default taper and default pressure grip value is not limited.
Wherein, in a specific embodiment of the present invention, above-mentioned second pressure hold configuration include: the second preheating temperature, it is second pre-
Hot time, the filling pressure force value that pressurising is carried out to foley's tube, the second pressure hold the second of machine and press the second diameter for holding hole, second directly
The reduction rate of diameter and the second molding retention time.
Wherein, the second pressure holds the pressure that hole is the distal end cooperation that the second pressure holds on machine bioabsorbable stent of holding that treated with precompressed
The pressure for holding piece holds hole.In this as an example, above-mentioned second pressure holds on machine the remote of bioabsorbable stent of holding that treated with precompressed
The pressure of end cooperation, which holds piece, to hold piece 4 for pressure as shown in Figure 5, correspondingly, second presses to hold on machine and hold that treated to inhale with precompressed
The pressure of the proximal end cooperation of revenue and expenditure frame, which holds piece, to hold piece 5 for pressure as shown in FIG. 6, correspondingly, it can be as shown in Figure 8 that the second pressure, which holds machine,
Pressure hold machine, which, which holds machine, has default taper.
It should be noted that the reduction rate that the second pressure holds the diameter that all pressures on machine hold hole can be identical, and then really
Protecting most final pressure and holding the bioabsorbable stent of completion is in that the outer diameter with the frustum cone structure and its distal end of presetting taper is less than the outer of proximal end
Diameter, while ensuring that most final pressure holds the bioabsorbable stent of completion and sacculus fits.
Specifically, in a specific embodiment of the present invention, above-mentioned second preheating temperature is 45 DEG C to 55 DEG C, preferably 50 DEG C；
Second preheating time was 10s to 60s, preferably 20s；The filling pressure force value for carrying out pressurising to foley's tube is 80~220psi, excellent
Select 150psi；Second diameter and precompressed hold that treated the outer diameter of distal end of bioabsorbable stent are identical, the reduction speed of second diameter
Rate is 0.01mm/s to 0.2mm/s, preferably 0.1mm/s；Second molding retention time was 20s to 180s, preferably 60s.
Wherein, in a specific embodiment of the present invention, the specific implementation of above-mentioned steps 201 includes the following steps:
Bioabsorbable stent is sheathed on the outside of a support construction by the first step, is obtained the second pressure and is held structure.
Wherein, in a specific embodiment of the present invention, above-mentioned support construction can be support mandrel or foley's tube etc..
Second step holds machine by the first pressure and holds configuration according to pre-set first pressure, holds structure to the second pressure and press
It holds, until the reduction that the first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount.
Wherein, in a specific embodiment of the present invention, above-mentioned predetermined amount can be the pre- of the current outer diameter of bioabsorbable stent
If percentage, which can be 5% to 12%, preferably 8%.
And in a specific embodiment of the present invention, it is above-mentioned first pressure hold configuration include: the first preheating temperature, first preheating when
Between, first pressure hold machine first pressure hold the first diameter in hole, the reduction rate of first diameter and first molding the retention time.Its
In, it is identical that the first pressure holds the first diameter that multiple first pressures that machine is included hold hole.In this as an example, above-mentioned first pressure
The pressure for holding machine, which holds piece, to hold piece 6 for pressure as shown in Figure 7, correspondingly, the first pressure, which holds machine, to hold machine for pressure as shown in Figure 9, it should
It is identical that pressure holds the first diameter that multiple first pressures that machine is included hold hole.
Specifically, in a specific embodiment of the present invention, above-mentioned first preheating temperature is 45 DEG C to 55 DEG C, preferably 50 DEG C；
First preheating time was 10s to 60s, preferably 20s；After first presses the first of machine of holding the first diameter for holding hole and precompressed is pressed to hold processing
The outer diameter of bioabsorbable stent identical (precompressed holds that treated, and bioabsorbable stent does not have taper, i.e., outer diameter everywhere is homogeneous
Together), the reduction rate of first diameter is 0.01mm/s to 0.2mm/s, preferably 0.1mm/s；First molding retention time was 10 seconds
To 60 seconds, preferably 30 seconds.
Third step, repeats and presses machine of holding to hold configuration according to pre-set first pressure by first, holds knot to the second pressure
Structure carries out pressure and holds, until the step of reduction that the first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount, until
The outer diameter of bioabsorbable stent, which is pressed, to be held to default outer diameter.
Wherein, in a specific embodiment of the present invention, above-mentioned default outer diameter can be 1.6mm to 1.9mm, preferably
1.75mm。
Wherein, in a specific embodiment of the present invention, primary above-mentioned second step, the outer diameter of bioabsorbable stent are executed due to every
Reduction it is less (the wherein preset percentage that the reduction of the outer diameter of bioabsorbable stent is its preceding outer diameter), and be that make can
The outer diameter for absorbing bracket, which is pressed, to be held to default outer diameter, it is therefore desirable to above-mentioned second step is executed repeatedly, until bioabsorbable stent is outer
Diameter, which is pressed, to be held to default outer diameter.It should be noted that during executing above-mentioned second step every time, when outside bioabsorbable stent
When the reduction of diameter reaches predetermined amount, the pressure grip value that the first pressure need to be made to hold machine is kept for the first molding retention time, with overcome can
Stress after absorption deformation of timbering inside releasable material.
4th step, from pressure hold after the second pressure hold and detach bioabsorbable stent in structure, obtain precompressed hold that treated can
Absorb bracket.
Wherein, in a specific embodiment of the present invention, precompressed holds that treated bioabsorbable stent does not have taper, everywhere
Outer diameter it is all the same, only when to the bioabsorbable stent carried out it is secondary pressure hold after, bioabsorbable stent can just have taper, reach
To bioabsorbable stent system is promoted in the handling capacity of lesion vessels and small size blood vessel, while bioabsorbable stent can also be reduced
The risk being detached from sacculus, effectively improves the effect for the safety that bioabsorbable stent uses.
It can be seen that in a specific embodiment of the present invention, holding processing by carrying out precompressed to bioabsorbable stent, and will be pre-
The outside of the sacculus of pressure holds that treated bioabsorbable stent is sheathed on foley's tube, obtains the first pressure and holds structure, finally to first
Pressure holds the secondary pressure of structure progress and holds to obtain bioabsorbable stent system, and making bioabsorbable stent is in the frustum cone structure with default taper,
And the outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of proximal end, so that during pushing bioabsorbable stent system,
Bioabsorbable stent system can be promoted in the handling capacity of lesion vessels and small size blood vessel, while bioabsorbable stent can also be reduced
The risk being detached from sacculus, effectively improves the safety that bioabsorbable stent uses.
The above is a preferred embodiment of the present invention, it is noted that for those skilled in the art
For, without departing from the principles of the present invention, it can also make several improvements and retouch, these improvements and modifications
It should be regarded as protection scope of the present invention.
Claims (7)
1. a kind of method for preparing bioabsorbable stent system, which is characterized in that the described method includes:
Precompressed is carried out to bioabsorbable stent and holds processing, the outer diameter of the bioabsorbable stent is pressed and holds to default outer diameter, obtain pre-
Pressure holds that treated bioabsorbable stent；
Precompressed bioabsorbable stent of holding that treated is sheathed on to the outside of the sacculus of foley's tube, the first pressure is obtained and holds structure；Its
In, the precompressed holds that treated, and bioabsorbable stent is located between the first predeterminated position and the second predeterminated position of the sacculus,
First predeterminated position is position corresponding with the first development point of the foley's tube on the sacculus, and described second is default
Position is position corresponding with the second development point of the foley's tube on the sacculus；
The secondary pressure of structure progress is held to first pressure to hold, the secondary bioabsorbable stent pressed after holding and the sacculus is made to fit,
Bioabsorbable stent after the secondary pressure is held is in the frustum cone structure with default taper and the secondary absorbable branch pressed after holding
The outer diameter of the distal end of frame is less than the outer diameter of proximal end, obtains bioabsorbable stent system；
Wherein the default taper is 0.008~0.017；The wall thickness of the bioabsorbable stent be 100 to 150 microns, it is described can
The outer diameter for absorbing the distal end of bracket is 0.8 to 1.2 millimeter, and the outer diameter of the proximal end of the bioabsorbable stent is 1.0 to 1.4 millimeters；
Wherein it is described to it is described first pressure hold structure carry out it is secondary pressure hold, make it is secondary pressure hold after bioabsorbable stent and the sacculus
It fits, the secondary bioabsorbable stent pressed after holding is in after holding with the frustum cone structure and the secondary pressure for presetting taper
The step of outer diameter of the distal end of bioabsorbable stent is less than the outer diameter of proximal end, obtains bioabsorbable stent system, comprising:
The second pressure by having default taper holds machine and holds configuration according to pre-set second pressure, carries out to the foley's tube
Pressurising, and to it is described first pressure hold structure carry out pressure hold, until it is described second pressure hold machine feedback pressure grip value reach default pressure
Grip value, the bioabsorbable stent after the bioabsorbable stent after holding secondary pressure fits with the sacculus, the secondary pressure is held are in
The outer diameter of distal end of bioabsorbable stent after frustum cone structure with default taper and the secondary pressure are held is less than the outer of proximal end
Diameter obtains bioabsorbable stent system.
2. making institute the method according to claim 1, wherein described hold processing to bioabsorbable stent progress precompressed
The step of outer diameter for stating bioabsorbable stent, which is pressed, to be held to default outer diameter, and precompressed bioabsorbable stent of holding that treated is obtained, comprising:
Bioabsorbable stent is sheathed on to the outside of a support construction, the second pressure is obtained and holds structure；
By first pressure hold machine according to it is pre-set first pressure hold configuration, to it is described second pressure hold structure carry out pressure hold, up to
The reduction that first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount；
Repeat it is described machine is held by the first pressure configuration is held according to pre-set first pressure, press described second hold structure into
Row pressure is held, until the step of reduction that first pressure holds the outer diameter of the bioabsorbable stent of machine feedback reaches predetermined amount,
Until the outer diameter of the bioabsorbable stent is pressed and is held to default outer diameter；
From pressure hold after the second pressure hold and detach the bioabsorbable stent in structure, obtain precompressed absorbable branch of holding that treated
Frame.
3. according to the method described in claim 2, it is characterized in that, it includes: the first preheating temperature, that first pressure, which holds configuration,
The first pressure that one preheating time, first pressure hold machine holds the first diameter in hole, the reduction rate of the first diameter and the
One molding retention time,
Wherein, the first diameter that multiple first pressures that first pressure holds that machine is included hold hole is identical.
4. according to the method described in claim 2, it is characterized in that, the predetermined amount is the current outer diameter of the bioabsorbable stent
Preset percentage.
5. the method according to claim 1, wherein the default pressure grip value is 150N~300N.
6. the method according to claim 1, wherein it includes: the second preheating temperature, that second pressure, which holds configuration,
The second pressure that two preheating times, the filling pressure force value that pressurising is carried out to the foley's tube, second pressure hold machine holds the of hole
Two diameters, the reduction rate of the second diameter and the second molding retention time,
Wherein, it is the distal end that second pressure holds on machine bioabsorbable stent of holding that treated with the precompressed that second pressure, which holds hole,
The pressure that the pressure of cooperation holds piece holds hole.
7. according to the method described in claim 6, it is characterized in that, second preheating temperature is 45 DEG C to 55 DEG C, described the
Two preheating times be 10s to 60s, to the foley's tube carry out pressurising filling pressure force value be 80~220psi, described second
Diameter and the precompressed hold that treated the outer diameter of distal end of bioabsorbable stent are identical, and the reduction rate of the second diameter is
0.01mm/s to 0.2mm/s, the second molding retention time is 20s to 180s.
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| CN113558833B (en) * | 2020-04-28 | 2023-03-07 | 元心科技(深圳)有限公司 | Pressing and holding method of bracket and bracket system |
| CN111870395B (en) * | 2020-07-27 | 2022-12-30 | 上海纽脉医疗科技有限公司 | Press-holding system and press-holding method |
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| CN201135683Y (en) * | 2007-11-07 | 2008-10-22 | 乐普（北京）医疗器械股份有限公司 | Conical saccule dilating catheter |
| CN202122762U (en) * | 2011-07-12 | 2012-01-25 | 孔祥军 | Balloon dilating catheter |
| CN104644293A (en) * | 2014-12-30 | 2015-05-27 | 上海百心安生物技术有限公司 | Pressing and holding method and pressing and holding structure of intravascular stent |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7381048B2 (en) * | 2005-04-12 | 2008-06-03 | Advanced Cardiovascular Systems, Inc. | Stents with profiles for gripping a balloon catheter and molds for fabricating stents |
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- 2017-03-28 CN CN201710191402.8A patent/CN106880428B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201135683Y (en) * | 2007-11-07 | 2008-10-22 | 乐普（北京）医疗器械股份有限公司 | Conical saccule dilating catheter |
| CN202122762U (en) * | 2011-07-12 | 2012-01-25 | 孔祥军 | Balloon dilating catheter |
| CN104644293A (en) * | 2014-12-30 | 2015-05-27 | 上海百心安生物技术有限公司 | Pressing and holding method and pressing and holding structure of intravascular stent |
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